Bone Health in Youth With Type 1 Diabetes

• Conditions: Type 1 Diabetes; Osteoporosis

• Registration Number: NCT02140424
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

This is an observational study of children and young adults ages 6-20 years with type 1 diabetes and age- and race-matched controls. The investigators will be examining blood and urine hormone levels as well as measures of bone density including DXA and high-resolution peripheral quantitiative computed tomography. The investigators will also be collecting data regarding physical activity via use of wearable accelerometers. The investigators hypothesize that youth with type 1 diabetes will have slower bone accrual and impaired bone microarchitectural integrity compared with non-diabetic controls, and that bones of individuals with type 1 diabetes will not respond as well to physical activity. The investigators hypothesize that poor bone accrual will be associated with sub-optimal glucose control as well as lower levels of insulin-like growth factor 1.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2014-05-13
• Study First Submitted QC: 2014-05-14
• Study First Posted: 2014-05-16
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-07
• Last Update Posted: 2020-10-09
• Primary Completion: 2023-07
• Study Completion: 2024-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 242

Inclusion Criteria

• Age 6-20 years
• Out of honeymoon period (cohort with diabetes)

Exclusion Criteria

• BMI<5th percentile for age
• BMI>95th percentile for age
• Celiac disease
• Hyperthyroidism, uncontrolled hypothyroidism
• History of significant hepatic disease, renal disease, oncologic disease, cardiovascular disease, psychiatric disease
• Anemia (Hgb <11)
• Taking medications other than insulin known to affect bone health (including hormonal contraception, glucocorticoids, growth hormone)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of bone mineral accrual	0, 12, 24 months	Bone mineral mass and density will be measured by dual-energy x-ray absorptiometry (DXA) at baseline and 12 months. Percent change over time will be calculated and then compared in subjects with type 1 diabetes and matched control subjects.

Secondary Outcome Measures

Name	Time	Method
Change bone microarchitectural parameters in patients with diabetes vs. controls	0 and 24 months	Bone microarchitecture will be assessed by high-resolution peripheral quantitative computed tomography (HR-pQCT) at 0 and 12 months. Parameters measured will include cortical compartment density, cortical thickness, cortical porosity, trabecular density, trabecular number, and trabecular thickness and percent change over 12 months will be calculated. Percent change will be compared in patients with diabetes and matched controls.
Cross-sectional comparison of bone microarchitectural parameters in patients with diabetes vs. controls	Baseline	Bone microarchitecture will be assessed by high-resolution peripheral quantitative computed tomography (HR-pQCT). Parameters measured will include cortical compartment density, cortical thickness, cortical porosity, trabecular density, trabecular number, and trabecular thickness.
Rate of bone mineral accrual	0 and 24 months	Bone mineral mass and density will be measured by dual-energy x-ray absorptiometry (DXA) at baseline and 24 months. Percent change over time will be calculated and then compared in subjects with type 1 diabetes and matched control subjects.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States